MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM-P STD STEM SIZE 7; HIP STEM CEMENTLESS

Catalog Number	01.18.407
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At 3 weeks from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 19 aug 2024.Lot 2000066: (b)(4) items manufactured and released on 05-may-2020.Expiration date: 2025-04-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implants revised.Batch review performed on 19 aug 2024 on ball heads: mectacer 01.29.212 biolox delta ceramic ball head 12/14 ø 40 size s - 4 (k112115) lot.2408720 lot 2408720: (b)(4) items manufactured and released on 22-apr-2024.Expiration date: 2029-04-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 19 aug 2024 on cup: mpact 01.32.160dh acetabular shell ø60 two-holes (k132879) lot.168450d lot 168450: (b)(4) items manufactured and released on 02-mar-2017.Expiration date: 2022-02-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Lot 168450d: (b)(4) item manufactured and released on 27-jul-2022.Expiration date: 2027-07-12.No anomalies found related to the problem.Batch review performed on 19 aug 2024 on liner: mpact 01.32.4052hct flat pe hc liner ø40/g (k122641) lot.2206912 lot 2206912: (b)(4) items manufactured and released on 02-jun-2022.Expiration date: 2027-05-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: STEM: AMISTEM-P STD STEM SIZE 7
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20154724
• Report Number: 3005180920-2024-00710
• Device Sequence Number: 4248171
• Product Code: LZO
• UDI-Device Identifier: 07630040720069
• UDI-Public: 07630040720069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2025
• Device Catalogue Number: 01.18.407
• Device Lot Number: 2000066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male